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PowerFlex 5yard
EUDAMEDClass I (EU MDR)
Ref 3815BK-048Model PowerFlex 5yardRef 3815GR-048Ref 3815OR-048Ref 3815NG-048Ref 3815LB-048Ref 3820GR-0200Ref 3815HP-048Ref 3815PU-048Ref 3815NP-048Ref 3815BL-048
Identity
- Trade Name
- PowerFlex 5yard EUDAMED
- Device Name
- COFLEX EUDAMED
- Model / Reference
- PowerFlex 5yard EUDAMED3815BK-048 EUDAMED3815GR-048 EUDAMED3815OR-048 EUDAMED3815NG-048 EUDAMED3815LB-048 EUDAMED3820GR-0200 EUDAMED3815HP-048 EUDAMED3815PU-048 EUDAMED3815NP-048 EUDAMED3815BL-048 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00724004385092 EUDAMED00724004385122 EUDAMED00724004401846 EUDAMED00724004385030 EUDAMED00724004385085 EUDAMED00724004382121 EUDAMED00724004401822 EUDAMED00724004385054 EUDAMED00724004385047 EUDAMED00724004385016 EUDAMED
- Basic UDI-DI
- 0724004PowerFlex5yardAX EUDAMED
- EMDN Code
- M030402020101 ELASTIC SUPPORT BANDAGES, COHESIVE, EXTENSIBLE IN ONE DIRECTION, HIGH EXTENSIBILITY EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Denmark EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
Yes
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
PowerFlex 5yard by Andover Healthcare Inc. — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 0724004PowerFlex5yardAX | Class I | Active |
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Manufacturer
- Manufacturer
- Andover Healthcare Inc.
- EUDAMED SRN
- US-MF-000035055
- Authorised Representative
- Advena Limited MT-AR-000000234
Sources (10)
- EUDAMED b51104ba-414a-41aa-a9ca-03bcb9b19d2e 61 fields · synced Oct 6, 2026
- EUDAMED f2baf627-e42c-45db-8c32-f5a1bbb71eca 61 fields · synced Jun 18, 2026
- EUDAMED b383067e-b42e-4cd7-b397-a7904bc3ceeb 61 fields · synced Jun 20, 2026
- EUDAMED cd7d4c9e-2f48-403b-841e-262e528ccdc3 61 fields · synced Jul 8, 2026
- EUDAMED 444eb80b-8222-4b95-bda0-79b9d4aba817 61 fields · synced Jul 12, 2026
- EUDAMED 81299956-69c0-455c-aa29-4f68c18d0790 61 fields · synced Jul 21, 2026
- EUDAMED 550e836c-be15-499d-bb8c-215f12a56a9a 61 fields · synced Jul 22, 2026
- EUDAMED f6c273e9-7733-4702-939c-5be508bf8248 61 fields · synced Jul 22, 2026
- EUDAMED 1d581a68-275e-4692-bb43-460f1941ff24 61 fields · synced Jul 30, 2026
- EUDAMED 4516e854-967c-4864-a69d-b717bb4259d0 61 fields · synced Aug 3, 2026